• Title/Summary/Keyword: multicentre

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An Open-Label, Multicentre, Observational, Post-Marketing Study to Monitor the Safety and Effectiveness of Umeclidinium/Vilanterol in Korean Patients

  • Eun-Yeong Cho;Jung-Eun Cho;Eun-Bin Lee;Seung Soo Yoo;Jung Hyun Chang
    • Tuberculosis and Respiratory Diseases
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    • v.86 no.1
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    • pp.33-46
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    • 2023
  • Background: Umeclidinium/vilanterol (UMEC/VI; ANORO ELLIPTA, GSK) is a commonly used dual bronchodilator. This study evaluated the safety and effectiveness of UMEC/VI in Korean patients with chronic obstructive pulmonary disease (COPD) over a 6-year period. Methods: This was an open-label, multicentre, observational, post-marketing surveillance study. A total of 3,375 patients were enrolled consecutively in 52 hospitals, by 53 physicians, between July 2014 and July 2020. Patients who were administered UMEC/VI (fixed-dose 62.5 ㎍/25 ㎍) at least once and were monitored for safety and effectiveness were included in the analysis. Incidence and severity of adverse events (AEs) reported after administrating at least one dose of UMEC/VI were monitored, including unexpected adverse events (UAEs) and adverse drug reactions (ADRs). Effectiveness of UMEC/VI after 24 weeks of administration was also assessed using physician's evaluation (effective, ineffective/no change, worsening, indeterminable) and lung function improvement. Results: Of 3,375 patients, 3,086 were included in the safety assessment group (mean age±standard deviation: 69.76±8.80 years; 85.9% male [n=2,652]; 73.1% aged ≥65 years [n=2,255]). The overall incidence of AEs was 28.8% (n=890), of which 2.2% (n=67) were ADRs. Serious AEs and UAEs were reported in 181 (5.9%) and 665 (21.6%) patients, respectively, and two patients (<0.1%) reported unexpected severe ADR. Of the 903/3,086 patients analysed for effectiveness, most (82.8%, n=748) showed overall disease improvement after UMEC/VI treatment. Conclusion: This study confirmed UMEC/VI administered to Korean patients according to the prescribing information was well-tolerated and can be considered an effective option for COPD treatment.

The Treatment of Adult Respiratory Distress Syndrome (ARDS) Using Extracorporeal Membrane Oxygenation (ECMO) (성인 호흡곤란 증후군에 있어 체외막 산소화 장치를 이용한 치료)

  • Kim, Go-Woon;Choi, Eun-Young;Hong, Sang-Bum
    • Tuberculosis and Respiratory Diseases
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    • v.72 no.1
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    • pp.1-7
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    • 2012
  • Extracorporeal Membrane Oxygenation (ECMO) support to tissue oxygenation has been shown to improve survival in patients with life threatening respiratory distress syndrome or cardiac failure. Extracorporeal life support such as ECMO, including extracorporeal $CO_2$ removal ($ECCO_2R$), is used as temporary support until successful recovery of organs. A recently published multicentre randomized controlled trial, known as the CESAR (conventional ventilation or extracorporeal membrane oxygenation for severe adult respiratory failure) trial, was the first trial to demonstrate the utility of ECMO in acute respiratory distress syndrome (ARDS). During the 2009 influenza A (H1N1) pandemic, there were many reports of patients with severe ARDS related to H1N1 infection treated with ECMO. These reports revealed a high survival rate and effectiveness of ECMO. In this review, we explain the indication of ECMO clinical application, the practical types of ECMO, and complications associated with ECMO. In addition, we explain recent new ECMO technology and management of patients during ECMO support.

Antifungal Susceptibility Tests and the cyp51 Mutant Strains among Clinical Aspergillus fumigatus Isolates from Korean Multicenters

  • Won, Eun Jeong;Joo, Min Young;Lee, Dain;Kim, Mi-Na;Park, Yeon-Joon;Kim, Soo Hyun;Shin, Myung Geun;Shin, Jong Hee
    • Mycobiology
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    • v.48 no.2
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    • pp.148-152
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    • 2020
  • We investigated the antifungal susceptibilities and the cyp51 mutant strains among Aspergillus fumigatus clinical isolates obtained from 10 university hospitals in Korea. Of the 84 isolates examined, two itraconazole-resistant isolates were found with no amino acid substitution in the cyp51A/cyp51B genes. However, 19 (23.2%) azole-susceptible isolates harbored amino acid substitutions: Nine isolates harbored one to five mutations in cyp51A with high polymorphism, and 11 isolates exhibited the same Q42L mutation in cyp51B. Overall, a low azole resistance rate and high frequency of cyp51A/cyp51B amino acid substitutions were observed in the azole-susceptible A. fumigatus isolates in Korea.

Prognostic Factors and Adjuvant Treatments for Surgically Treated Cancers of the Biliary Tract: A Multicentre Study of the Anatolian Society of Medical Oncology (ASMO)

  • Unal, Olcun Umit;Oztop, Ilhan;Assoc, Tugba Kos;Turan, Nedim;Kucukoner, Mehmet;Helvaci, Kaan;Berk, Veli;Sevinc, Alper;Yildiz, Ramazan;Cinkir, Havva yesil;Tonyali, Onder;Demirci, Umut;Aktas, Bilge;Balakan, Ozan;Yilmaz, Ahmet Ugur
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.22
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    • pp.9687-9692
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    • 2014
  • Background: Biliary tract cancers are rare, and surgical resection is the standard treatment at early stages. However, reports on the benefits of adjuvant treatment following surgical resection are conflicting. This study aimed to evaluate the factors affecting survival and adjuvant treatments in patients with surgically treated biliary tract cancers. Materials and Methods: Patient clinical features, adjuvant treatments, and efficacy and prognostic factor data were evaluated. Survival analyses were performed using SPSS 15.0. Results: The median overall survival was 30.7 months (95% confidence interval [CI], 18.4-42.9 months). Median survival was 19 months (95% CI, 6-33) for patients treated with fluorouracil based chemotherapy and 53 months (95% CI, 33.2-78.8) with gemcitabine based chemotherapy(p=0.033). On univariate analysis, poor prognostic factors for survival were galbladder localization, perineural invasion, hepatic invasion, a lack of adjuvant chemoradiotherapy treatment, and a lack of lymph node dissection. On multivariate analysis, perineural invasion was a poor prognostic factor (p=0.008). Conclusions: Biliary tract cancers generally have poor prognoses. The main factors affecting survival are tumour localization, perineural invasion, hepatic invasion, adjuvant chemoradiotherapy, and lymph node dissection. Gemcitabine-based adjuvant chemotherapy is more effective than 5-fluorouracil-based chemotherapy.

Clinical Prognostic Factors and Survival Outcome in Renal Cell Carcinoma Patients - A Malaysian Single Centre Perspective

  • Yap, Ning Yi;Ng, Keng Lim;Ong, Teng Aik;Pailoor, Jayalakshmi;Gobe, Glenda Carolyn;Ooi, Chong Chien;Razack, Azed Hassan;Dublin, Norman;Morais, Christudas;Rajandram, Retnagowri
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.12
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    • pp.7497-7500
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    • 2013
  • Background: This study concerns clinical characteristics and survival of renal cell carcinoma (RCC) patients in University Malaya Medical Centre (UMMC), as well as the prognostic significance of presenting symptoms. Materials and Methods: The clinical characteristics, presenting symptoms and survival of RCC patients (n=151) treated at UMMC from 2003-2012 were analysed. Symptoms evaluated were macrohaematuria, flank pain, palpable abdominal mass, fever, lethargy, loss of weight, anaemia, elevated ALP, hypoalbuminemia and thrombocytosis. Univariate and multivariate Cox regression analyses were performed to determine the prognostic significance of these presenting symptoms. Kaplan Meier and log rank tests were employed for survival analysis. Results: The 2002 TNM staging was a prognostic factor (p<0.001) but Fuhrman grading was not significantly correlated with survival (p=0.088). At presentation, 76.8% of the patients were symptomatic. Generally, symptomatic tumours had a worse survival prognosis compared to asymptomatic cases (p=0.009; HR 4.74). All symptoms significantly affect disease specific survival except frank haematuria and loin pain on univariate Cox regression analysis. On multivariate analysis adjusted for stage, only clinically palpable abdominal mass remained statistically significant (p=0.027). The mean tumour size of palpable abdominal masses, $9.5{\pm}4.3cm$, was larger than non palpable masses, $5.3{\pm}2.7cm$ (p<0.001). Conclusions: This is the first report which includes survival information of RCC patients from Malaysia. Here the TNM stage and a palpable abdominal mass were independent predictors for survival. Further investigations using a multicentre cohort to analyse mortality and survival rates may aid in improving management of these patients.

Multicentre Hospital-based Case-control Study of Diffuse Large B-cell Lymphoma in Shanghai, China

  • Fan, Rong;Zhang, Lu-Yao;Wang, Hong;Yang, Bo;Han, Tao;Zhao, Xiao-Li;Wang, Wei;Wang, Xiao-Qin;Lin, Guo-Wei
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.7
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    • pp.3329-3334
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    • 2012
  • Background: Several potential risk factors have been identified for diffuse large B-cell lymphoma (DLBCL); however, epidemiological studies investigating the association between these risk factors and DLBCL have yielded inconsistent results. Objectives: To investigate potential medical, lifestyle, and environmental risk factors of DLBCL in Shanghai, China through a hospital-based case-control study. Method: One-hundred-and-forty-seven newly diagnosed DLBCL patients and 294 sex- and age-matched controls were recruited from 11 hospitals in Shanghai between 2003 and 2007. A standardized structured questionnaire was used to obtain patient data on demographics, medical history, family history, lifestyle, and environmental exposures. Conditional logistic regression models were used to estimate odds ratios (ORs), with 95% confidence intervals (CIs), for risk associated with each data category. Results: History of tuberculosis (TB) infection and "living on a farm" were positively associated with DLBCL (TB: OR=3.05, 95% CI: 1.19-7.80; farm: OR=1.82, 95% CI: 1.21-2.73). In contrast, taking traditional Chinese medicine was negatively associated with DLBCL (OR=0.36, 95% CI: 0.14-0.89). No significant correlation with DLBCL risk was found for any of the other potential risk factors (p>0.05), including but not limited to hair dyes, alcohol drinking, smoking, and home/workplace renovation within one year. Conclusions: Consistent with results from previous studies in other DLBCL case populations, traditional Chinese medicine appeared to have a direct or indirect protective effect against DLBCL. However, this study also identified a possible predisposition for DLBCL in TB sufferers and farmers.

The Analysis of Registration Status of Interventional Clinical Trials for Children and Adolescents with Chronic Cough - Focused on WHO ICTRP - (소아 청소년 만성기침 환자를 대상으로 한 중재 임상시험 등록 현황 분석 - WHO ICTRP를 중심으로 -)

  • Jeong Yoon Kyoung;Choi Seo Yeon;Bang Miran;Lee Jun-Hwan;Lee Boram;Chang Gyu Tae
    • The Journal of Pediatrics of Korean Medicine
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    • v.37 no.3
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    • pp.75-93
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    • 2023
  • Objectives We aimed to analyze the registration status of interventional clinical trials in children and adolescents with chronic cough. Methods All interventional clinical trials registered up to 3 July, 2023 on the international clinical trial registry platform (ICTRP) of the World Health Organization (WHO) were analyzed. Information was extracted including study design, interventions, inclusion and exclusion criteria, and outcome indicators. Results A total of 18 interventional clinical trials were analyzed. For study design, multicentre trials, randomized allocation, parallel group design and phase 4 trials were the most frequently reported. Blinding was used in 44.4% and informed consents were obtained from 61.1%. For intervention, drugs were used in 61.1%, using placebo control group in 27.8%. Quality of life questionnaires were most frequently reported in 50% as the primary outcome, and adverse events were the most as the secondary outcome. In most cases, the assessment timepoints were after two weeks. Conclusions Based on the characteristics of clinical trial design analyzed in this study, it is necessary to design traditional Korean medicine clinical trials with improved quality and accuracy of information.

Robust Reference Intervals for Serum Kappa and Lambda Free Light Chains from a Multi Centre Study Population from Hyderabad, India: Myeloma Diagnostic Implications

  • Mohammed, Noorjahan;Chandran, Priscilla Abraham;Kandregula, Madhavi;Mattaparthi, Ratna Deepika;Gundeti, Sadasivudu;Volturi, Jyotsna;Darapuneni, Radhika;Raju, Sree Bhushan;Dattatreya, Palanki Satya
    • Asian Pacific Journal of Cancer Prevention
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    • v.17 no.5
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    • pp.2605-2610
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    • 2016
  • The International Myeloma Working Group considers the serum free light chain (SFLC) assay to be an adjunct to traditional tests. Apart from the FLC ratio, the absolute values of individual free light chains also are gaining importance as they appear to be more relevant in certain clinical settings. Automated assays are available for their determination. As laboratories put new test systems into use catering to different disease populations, they are required by accreditation and certification bodies to verify or establish performance specifications, including reference intervals (RIs) representative of their population. Our aim was to establish local RIs for SFLC in a multicentre representative healthy population using a robust method. There was no significant relationship between SFLC levels and age, gender and creatinine levels. The 95% RI for ${\kappa}SFLC$ was 4.81 to 33.86mg/L, for ${\lambda}$ SFLC was 5.19 to 23.67mg/L and for ${\kappa}/{\lambda}SFLC$ was 0.36 to 2.33, significantly higher than the values given by the manufacturer. The ${\kappa}/{\lambda}$ SFLC ratio at 2.23, covering 100% of the data, showed 72% sensitivity (95% CI=39.0 - 94.0), 100% specificity (95% CI=71.5 - 100.0), 100% PPV (95% CI=21.5 - 100.0), 95% NPV (95% CI=75.4 - 99.9), and 79% accuracy (95% CI=56.0 - 93.0). In the patient group, kit RI for ${\kappa}/{\lambda}$ SFLC ratio classified 45.5% (n=5) as positive vs 9.1% (n=1) positive by the study RI, while the kit RI for kappa FLC classified 90.9% (n=10) as positive vs 54.5% (n=6), indicating increased probability of false positive test results with the kit RI when applied to our patient population. Appropriate and specific reference intervals and criteria values result in fewer false-positive and false-negative results which means fewer wrong or missed diagnoses.

Health Promoting Lifestyle Behaviour in Medical Students: a Multicentre Study from Turkey

  • Nacar, Melis;Baykan, Zeynep;Cetinkaya, Fevziye;Arslantas, Didem;Ozer, Ali;Coskun, Ozlem;Bati, Hilal;Karaoglu, Nazan;Elmali, Ferhan;Yilmaze, Gulay
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.20
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    • pp.8969-8974
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    • 2014
  • Background: The aim of this study was to determine the predictors of health promoting lifestyle behaviour among medical students attending seven of the medical schools in Turkey. Materials and Methods: This crosssectional descriptive study was performed during the second semester of the first and last (sixth) years of study from March to May 2011. A questionnaire with two sections was specifically designed. The first section contained questions on demographic characteristics; the second consisted of the Health Promoting Lifestyle Profile II (HPLP) Scale. From a total of 2,309 medical students, 2,118 (response rate 91.7%) completed the questionnaire. Data were analyzed using descriptive statistics, t, Anova, Tukey test and binary logistic regression analysis. The research was approved by the Ethics Committee of Erciyes University. Results: The mean age was $20.7{\pm}2.9$ years and it was found that 55.1% were men, 62.3% were in the first year. The overall prevalence of smoking was 19.1%, and for drinking alcohol was 19.4%. HPLP point averages of the first year students were $129.2{\pm}17.7$, and for last year $125.5{\pm}19.0$. The overall mean score for the HPLP II was $2.5{\pm}0.4$. They scored highest on the spiritual growth subscale ($2.9{\pm}0.5$), interpersonal relations ($2.8{\pm}0.5$), health responsibility subscale ($2.3{\pm}0.5$), nutrition subscale ($2.3{\pm}0.5$), stress management subscale ($2.3{\pm}0.4$), and the lowest subscale physical activity ($2.0{\pm}0.5$). It is established that student's grade, educational level of parents, economic status of family, marital status, smoking and general health perception of the students resulted in a significant difference in HPLP Scale total score average and the mean score of majority of subscales. There was no statistically significant difference between the total HPLP when evaluated for gender, chronic disease, alcohol drinking status and BMI. Conclusions: Based on these results, particularly in the curriculum of medical students in order to increase positive health behaviours including physical activity, health promotion issues, and giving more space to aim at behaviour change in these matters is recommended.